Define and lead global regulatory strategy for clinical-stage radiopharmaceutical programs.
Lead key regulatory submissions including INDs, CTAs, and DMFs.
Serve as primary contact for regulatory agencies and build strong relationships with health authorities.
ARTBIO discovers and develops a new class of Alpha Radioligand Therapies (ARTs) to redefine cancer care. It is a global biotech with offices in Boston, Basel, London, and Oslo, fostering a collaborative and supportive culture.
Support the development and execution of clinical regulatory strategies for assigned programs across regions.
Prepare and manage IND applications and other regulatory submissions, ensuring accuracy and timely delivery.
Provide regulatory guidance to cross-functional teams and participate in health authority interactions.
Zai Lab is an innovative, research-based biopharmaceutical company based in China and the US, focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients worldwide. Founded in 2014, Zai Lab has a global team of approximately 2000 employees and is committed to gender diversity and environmental responsibility.
Develop and lead integrated global regulatory strategies for I&I pipeline programs.
Serve as primary regulatory strategist and Health Authority relationship lead.
Provide expert guidance on development plan design and filing strategies.
Beeline Medicines is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases. It is a small company backed by world-class investors, with a culture of scientific rigor and operational excellence.
Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory submissions.
Provide hands-on CMC regulatory expertise across global filings, health authority interactions, and post-approval activities.
Collaborate with cross-functional teams to align regulatory strategy with scientific and compliance requirements.
The company is a biotechnology organization developing innovative cell therapies for late-stage and commercial stages. It offers a collaborative, entrepreneurial, and innovative work environment with a fast-paced, senior-level team.
Provide regulatory strategy and guidance across the clinical development lifecycle, including submissions to Regulatory Authorities and Ethics Committees.
Coordinate and prepare regulatory documents such as CTA/IND, annual reports, amendments, orphan designations, and marketing applications.
Represent Global Regulatory Affairs at project team meetings, lead submission projects, and mentor Regulatory Affairs Specialists.
Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences, focusing on Oncology and Rare Disease. They are a growing global team that values employee contributions and fosters an environment where ideas are valued and nurtured.
Provide clinical, scientific, and strategic expertise to drug development programs from lead compound identification to launch.
Lead execution of clinical development plans, including trial documents, regulatory interactions, and cross-functional alignment.
Establish and maintain relationships with external medical experts and represent Ipsen at investigator meetings and scientific conferences.
Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With teams in more than 40 countries, it champions human-centric leadership and fosters a culture of collaboration, excellence and impact.
Own regulatory review and approval of promotional materials across HCP, DTC, digital, and social channels, ensuring compliance with FDA regulations.
Partner with Commercial, Medical Affairs, and Legal to shape campaigns and claims, providing clear guidance to reduce approval delays.
Lead FDA promotional submissions, monitor regulatory trends, and build scalable processes to support product launches.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. The company values Trust, Ownership, Curiosity, and Results, and offers a collaborative, high-achieving environment with a focus on diversity and inclusion.
Support operational execution of clinical studies from initial synopsis through final deliverables.
Manage implementation, on-time execution, and conduct of clinical studies, including budget and vendor management.
Oversee cross-functional study teams and ensure compliance with regulations and data integrity.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy.
Provide medical direction and scientific leadership for the pancreatic and colorectal cancer programs.
Lead clinical study subteams, design efficient clinical trials, and monitor safety and efficacy data.
Contribute to global regulatory filings, author clinical documents, and present at scientific meetings.
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for patients with cancer. The company's programs target the RAS/MAPK pathway, and it is driven by an audacious mission to erase cancer.
Supports clinical trial design, protocol development, and data interpretation to ensure high-quality data generation.
Provides medical expertise in therapeutic areas, reviews safety data, and contributes to regulatory documents.
Collaborates cross-functionally with clinical operations, regulatory affairs, and other teams to align clinical activities with development plans.
Oruka Therapeutics is developing novel biologics for chronic skin diseases. As a publicly traded biotechnology company with a startup culture, it focuses on offering patients greater freedom from conditions like plaque psoriasis.
Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulatory requirements.
Review electronic medical records and source documentation for accuracy and data integrity.
Support site staff and contribute to development of trial materials, SOPs, and training guides.
Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve transplant outcomes for blood cancer patients. The company maintains a start-up culture with an entrepreneurial spirit and emphasis on camaraderie.
Engage in meaningful strategic discussions with key oncology thought leaders to gather insights and share clinical information.
Coordinate thought leader engagements for senior executives at national/regional conferences and day-to-day interactions.
Ensure all interactions comply with company policies and industry regulations.
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. With over 30 years of history and nine FDA-approved treatments, we have an award-winning culture of innovation and are recognized as a Great Place to Work.
Lead the design and execution of clinical studies, including investigator-initiated trials and registries.
Develop evidence-generation strategies supporting CLIA validation and reimbursement pathways.
Build relationships with key opinion leaders in head & neck oncology and represent CareDx at conferences.
CareDx, Inc. is a leading precision medicine solutions company focused on transplant patients, offering products, testing services, and digital healthcare solutions. With a focus on genomics-based information, the company aims to improve the lives of organ transplant patients worldwide.
Responsible for site activation readiness, submission preparation, and interaction with Competent Authorities and Ethics Committees.
Manage essential document collection, informed consent customization, and maintain project plans and trackers.
Partner with cross-functional teams and act as subject matter expert for country-specific regulatory knowledge.
We are a global life sciences company specializing in clinical trial regulatory and start-up services. We are expanding our capabilities across Latin America and seek experienced professionals to join our team.
Lead biopharma oncology partnerships, developing new accounts and growing existing relationships.
Execute complex deals including proposals, pricing, contract negotiations, and closing agreements.
Collaborate cross-functionally with R&D, commercial, legal, and finance to deliver excellent partner experiences.
Guardant Health is a precision oncology company using advanced blood and tissue tests, real-world data, and AI to extend cancer-free time. Founded in 2012, it maintains a collaborative culture and is recognized as a top workplace.
Execute 8-12 MD-level engagements per quarter within a defined geography, with at least 50% in top strategic accounts.
Maintain 3 field ride days per month alongside MSL counterparts and engage 100% of flagged accounts within 10 business days.
Deliver scientific education, support regional programs, and document exchange summaries in Salesforce.
Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply about the work and each other.
Lead risk management and safety data review for assigned products, ensuring regulatory compliance.
Provide safety-related content for clinical and regulatory documents, and prepare for inspections.
Mentor a small pharmacovigilance team while driving end-to-end operational oversight.
Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies for blood cancer patients. We maintain a start-up culture of camaraderie and leadership by example, with a small dedicated team.
Lead regulatory and PV deliverables for complex projects, ensuring compliance and timely execution.
Provide strategic regulatory guidance and support business development through proposals and budgets.
Mentor and train junior staff, prepare invoices, and ensure audit readiness.
PrimeVigilance is a global pharmacovigilance specialist helping clients navigate complex regulations while keeping patient safety at the center of every decision. With teams across Europe, North America, South America, Asia, and Australia, we foster a culture built on kindness, flexibility, growth, and belonging.